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510(k) Data Aggregation
K Number
K073048Device Name
PETERIO UNIVERSAL LASER SCANNING HANDPIECE
Manufacturer
Date Cleared
2008-02-28
(122 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SCILEX, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Peterio Universal Laser Scanning Handpiece is intended to be used as an accessory to a compatible non-ablative 1064nm laser and for its legally marketed, dermatological indications including: Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin; Coagulation and hemostasis of sub-surface vascular lesions.
Device Description
The Peterio™ Universal Laser Scanning Handpiece is an accessory for a legally marketed, compatible laser system. It is hand held device which attaches to the distal end of the laser system and delivers rapid scanning of the laser beam over a predetermined surface area. The Peterio has been designed for delivering the energy fluence equivalent to that of legally marketed compatible lasers, to a confined volume at a selectable tissue depth, while at the same time the Peterio exposes the tissue surface to less than 10% of the fluence of such lasers.
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